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Surface Topography and Radiographic Spinal Damage in Radiographic Axial Spondyloarthritis

28. september 2026 oppdatert av: Seyma Alkan, Ankara Etlik City Hospital

Association Between Static Spinal Posture Assessed by Surface Topography (DIERS) and Radiographic Structural Damage (mSASSS) in Radiographic Axial Spondyloarthritis: A Cross-Sectional Study

Radiographic axial spondyloarthritis (r-axSpA) causes progressive structural damage of the spine, conventionally quantified on lateral cervical and lumbar radiographs using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Repeated radiography entails cumulative radiation exposure, substantial inter-reader variability and low sensitivity in early disease. DIERS Formetric 4D surface topography provides radiation-free three-dimensional modelling of the spine and pelvis. The association between sagittal balance and structural damage has been demonstrated with a radiation-based system (EOS), but whether a radiation-free topographic method reflects the same association has not been investigated.

This single-centre, cross-sectional observational study will enrol 53 adults with r-axSpA fulfilling the ASAS criteria with radiographic sacroiliitis according to the modified New York criteria. At a single study visit, static DIERS Formetric 4D measurements, chest expansion, BASMI, BASDAI, BASFI and ASDAS-CRP are obtained. mSASSS is scored by two independent readers, blinded to clinical and topographic data, on existing lateral cervical and lumbar radiographs obtained within the preceding 12 months; no additional radiographs are performed for the study. The primary analysis is the correlation between total mSASSS and the DIERS fleche cervicale (cervical sagittal anterior displacement).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Design: single-centre, cross-sectional, non-interventional correlation study in a single patient group; no control group. All participant data are collected in one assessment session lasting approximately 45 to 60 minutes.

Measurements: (a) demographic and anthropometric data; (b) disease duration, age at symptom onset, comorbidities, extra-articular involvement (uveitis, inflammatory bowel disease, psoriasis), HLA-B27 status, current medication category; (c) radiographic sacroiliitis grade according to the modified New York criteria and mSASSS (range 0 to 72), scored independently by two blinded readers with inter-reader agreement reported as the intraclass correlation coefficient; (d) chest expansion; (e) BASDAI, BASFI and ASDAS-CRP, the latter using routine C-reactive protein values with no additional blood sampling; (f) BASMI total score and its five components; (g) DIERS Formetric 4D static parameters: fleche cervicale (cervical sagittal anterior displacement, mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).

Statistical analysis: distribution is assessed with the Shapiro-Wilk test. The primary analysis is a Pearson or Spearman correlation between total mSASSS and fleche cervicale, reported with effect size and 95% confidence interval, followed by multiple linear regression adjusted for age and disease duration. Secondary analyses comprise correlations of DIERS parameters with clinical indices and an exploratory receiver operating characteristic analysis of the ability of DIERS sagittal parameters to predict prespecified mSASSS thresholds. The Benjamini-Hochberg procedure is applied to correct for multiple comparisons. Significance is set at p<0.05. Analyses are performed with IBM SPSS version 23 or later.

Sample size: calculated with G*Power 3.1.9 for a bivariate normal correlation model, two-tailed, rho H0 = 0, expected effect size r = 0.40, alpha = 0.05 and power = 0.85, giving a required sample of 53 participants (actual power 0.857). The effect size was set conservatively at r = 0.40 rather than the r = 0.61 reported by Wanders et al.

(2005) for occiput-to-wall distance versus mSASSS, because DIERS parameters are not identical to clinical mobility measures.

Reporting follows the STROBE statement.

Studietype

Observasjonsmessig

Registrering (Antatt)

53

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Tyrkia (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Tyrkia (Türkiye), 06560
        • Rekruttering
        • Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Consecutive patients with radiographic axial spondyloarthritis attending the spondyloarthritis outpatient clinic of the Department of Physical Medicine and Rehabilitation, Ankara Etlik City Hospital.

Beskrivelse

Inclusion Criteria:

  • Age 18 to 65 years
  • Diagnosis of radiographic axial spondyloarthritis fulfilling the ASAS criteria, confirmed by radiographic sacroiliitis according to the modified New York criteria
  • Able to provide written informed consent and to complete the assessments
  • Available lateral cervical and lumbar radiographs obtained within the 12 months preceding the DIERS measurement

Exclusion Criteria:

  • Neurological disease affecting balance, posture or gait (for example Parkinson disease, amyotrophic lateral sclerosis, cerebellar or vestibular disorders, history of stroke)
  • History of lower extremity joint arthroplasty (hip or knee)
  • Orthopaedic conditions affecting posture, balance or gait (ununited fracture, previous spinal or lower extremity surgery)
  • Advanced cardiopulmonary disease, active infection or malignancy
  • Pregnancy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: CROSS_SECTIONAL

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Radiographic axial spondyloarthritis patients

Adults aged 18 to 65 years with radiographic axial spondyloarthritis fulfilling the ASAS classification criteria with radiographic sacroiliitis according to the modified New York criteria, attending the spondyloarthritis outpatient clinic. All participants undergo a single assessment session including static DIERS Formetric 4D surface topography, clinical indices (BASDAI, BASFI, BASMI, ASDAS-CRP) and chest expansion. mSASSS is scored on existing lateral cervical and lumbar radiographs obtained within the preceding 12 months; no additional radiographs are taken.
Diagnostisk test: DIERS Formetric 4D surface topography

Radiation-free three-dimensional assessment of spinal and pelvic surface topography performed once in standing position. No radiation, no contact, no intervention on treatment.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation between total mSASSS and DIERS fleche cervicale
Tidsramme: Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

Total modified Stoke Ankylosing Spondylitis Spine Score (mSASSS; range 0 to 72, higher scores indicate greater structural damage), calculated as the mean of two independent blinded readers, correlated with fleche cervicale (cervical sagittal anterior displacement, mm) measured by DIERS Formetric 4D surface topography. Reported as a correlation coefficient with magnitude, direction and 95% confidence interval.
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation between total mSASSS and other DIERS Formetric static parameters
Tidsramme: Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

Total mSASSS (range 0 to 72, higher scores indicate greater structural damage) correlated with the remaining DIERS Formetric 4D static parameters: sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical depth distance (mm), lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees). Reported as correlation coefficients with 95% confidence intervals.
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment
Correlation between DIERS sagittal parameters and BASDAI
Tidsramme: Single assessment session (Day 1)

Bath Ankylosing Spondylitis Disease Activity Index (range 0 to 10, higher scores indicate greater disease activity) correlated with DIERS sagittal parameters.
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and BASFI
Tidsramme: Single assessment session (Day 1)

Bath Ankylosing Spondylitis Functional Index (range 0 to 10, higher scores indicate worse physical function) correlated with DIERS Formetric 4D static parameters: fleche cervicale (mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and BASMI
Tidsramme: Single assessment session (Day 1)

Bath Ankylosing Spondylitis Metrology Index (range 0 to 10, higher scores indicate worse spinal mobility) correlated with DIERS Formetric 4D static parameters: fleche cervicale (mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and ASDAS-CRP
Tidsramme: Single assessment session (Day 1)

Ankylosing Spondylitis Disease Activity Score with C-reactive protein (higher scores indicate greater disease activity) correlated with DIERS Formetric 4D static parameters: fleche cervicale (mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and chest expansion
Tidsramme: Single assessment session (Day 1)

Chest expansion measured in centimetres correlated with DIERS Formetric 4D static parameters: fleche cervicale (mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).
Single assessment session (Day 1)
Discriminative performance of DIERS sagittal parameters for mSASSS thresholds
Tidsramme: Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

Exploratory receiver operating characteristic analysis of DIERS Formetric 4D sagittal parameters for discriminating prespecified total mSASSS thresholds. Reported as area under the curve with 95% confidence interval, sensitivity and specificity.
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ankara Etlik City Hospital

Etterforskere

  • Hovedetterforsker: Ajda Bal, Professor of Physical Medicine and Rehabilitation

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. september 2026

Primær fullføring (Antatt)

20. juni 2027

Studiet fullført (Antatt)

20. august 2027

Datoer for studieregistrering

Først innsendt

28. september 2026

Først innsendt som oppfylte QC-kriteriene

28. september 2026

Først lagt ut (Faktiske)

2. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AEŞH-BADEK1-2026-048

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared. According to the approved protocol, research data are accessible only to the investigators. Aggregate results will be published.

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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